TY - JOUR
T1 - Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study)
T2 - Statistical analysis plan
AU - Onland, Wes
AU - Merkus, Maruschka P.
AU - Nuytemans, Debbie H.
AU - Jansen-van der Weide, Marijke C.
AU - Holman, Rebecca
AU - van Kaam, Anton H.
AU - Cools, Filip
AU - Rademaker, Karin
AU - Mohns, Thilo
AU - Blom, Henry
AU - Marechal, Yoann
AU - Debeer, Anne
AU - Dijk, Peter H.
AU - van Heijst, Arno F.
AU - Kramer, Boris W.
AU - Kroon, Andre
AU - van Straaten, Henriette L.
AU - Te Pas, Arjan B.
AU - Theyskens, Claire
AU - Zonnenberg, I.
AU - Plaskie, Katleen
AU - Sijmons, Marit
AU - Rigo, Vincent
AU - Keymeulen, Annelies
AU - SToP-BPD Study Group
N1 - Funding Information:
The StoP-BPD trial is funded by a project grant (no. 11-32010-02) from The Netherlands Organisation for Health Research and Development (ZonMw) Priority Medicines for Children programme.
Publisher Copyright:
© 2018 The Author(s).
PY - 2018/3/9
Y1 - 2018/3/9
N2 - Background: Bronchopulmonary dysplasia (BPD) is the most common complication of preterm birth with short-term and long-term adverse consequences. Although the glucocorticoid dexamethasone has been proven to be beneficial for the prevention of BPD, there are concerns about an increased risk of adverse neurodevelopmental outcome. Hydrocortisone has been suggested as an alternative therapy. The aim of the Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (SToP-BPD) trial is to assess the efficacy and safety of postnatal hydrocortisone administration for the reduction of death or BPD in ventilator-dependent preterm infants. Methods/design: The SToP-BPD study is a multicentre, double-blind, placebo-controlled hydrocortisone trial in preterm infants at risk for BPD. After parental informed consent is obtained, ventilator-dependent infants are randomly allocated to hydrocortisone or placebo treatment during a 22-day period. The primary outcome measure is the composite outcome of death or BPD at 36 weeks postmenstrual age. Secondary outcomes are short-term effects on pulmonary condition and long-term neurodevelopmental sequelae assessed at 2 years corrected age. Complications of treatment, other serious adverse events and suspected unexpected serious adverse reactions are reported as safety outcomes. This pre-specified statistical analysis plan was written and submitted without knowledge of the unblinded data.
AB - Background: Bronchopulmonary dysplasia (BPD) is the most common complication of preterm birth with short-term and long-term adverse consequences. Although the glucocorticoid dexamethasone has been proven to be beneficial for the prevention of BPD, there are concerns about an increased risk of adverse neurodevelopmental outcome. Hydrocortisone has been suggested as an alternative therapy. The aim of the Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (SToP-BPD) trial is to assess the efficacy and safety of postnatal hydrocortisone administration for the reduction of death or BPD in ventilator-dependent preterm infants. Methods/design: The SToP-BPD study is a multicentre, double-blind, placebo-controlled hydrocortisone trial in preterm infants at risk for BPD. After parental informed consent is obtained, ventilator-dependent infants are randomly allocated to hydrocortisone or placebo treatment during a 22-day period. The primary outcome measure is the composite outcome of death or BPD at 36 weeks postmenstrual age. Secondary outcomes are short-term effects on pulmonary condition and long-term neurodevelopmental sequelae assessed at 2 years corrected age. Complications of treatment, other serious adverse events and suspected unexpected serious adverse reactions are reported as safety outcomes. This pre-specified statistical analysis plan was written and submitted without knowledge of the unblinded data.
KW - Bronchopulmonary dysplasia
KW - Hydrocortisone
KW - Mortality
KW - Preterm
KW - Statistical analysis plan
U2 - 10.1186/s13063-018-2505-y
DO - 10.1186/s13063-018-2505-y
M3 - Article
SN - 1745-6215
VL - 19
JO - Trials
JF - Trials
IS - 1
M1 - 178
ER -